Onyx files FDA application for quick drug review

BenFox

Onyx Pharmaceuticals Inc.
ONXX
said it submitted a new drug application to the U.S. Food and Drug Administration, seeking accelerated approval for its blood cancer drug.

Carfilzomib, a proteasome inhibitor, could be used to treat patients with relapsed or stubborn multiple myeloma, a cancer of blood cells in bone marrow. Onyx also has requested priority review, to further speed up the FDA process.

"While important strides have been made in treating patients with multiple myeloma in the last decade, this disease remains uniformly fatal, underscoring the need for new treatment options," said Ted W. Love, executive vice president for Onyx's research and development operations.

The submission process began in January, after the drug received fast-track designation, a expedited review process of drugs that would treat serious or life-threatening diseases and fill an unmet medical need.

Carfilzomib was developed by Proteolix Inc., which Onyx acquired in late 2009 for $276 million plus potential milestone payments. Carfilzomib would diversify Oynx's product offering and also bring in more beneficial economics than the profit split it has with Nexavar, its cancer drug it sells with Germany's Bayer AG (BAYRY, BAYN.XE).

Shares closed Tuesday at $31.19 and were inactive premarket. The stock is up 15% year to date.

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